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Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The Relieva Sinus Balloon Catheter is a catheter designed to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

The Relieva Acella Sinus Balloon Catheter is a catheter designed to access and to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

The provided FDA 510(k) summary for the Acclarent Relieva™ Sinus Balloon Catheter and Relieva Acella™ Sinus Balloon Catheter indicates that the devices met all performance acceptance criteria. However, due to the nature of this submission (a traditional 510(k) for a medical device that does not involve AI/software for diagnostic purposes), the detailed information typically associated with AI/software performance studies is not present.

Here's an analysis of what can and cannot be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

Reasoning: The document states, "The Relieva Sinus Balloon Catheter met all performance acceptance criteria. The Relieva Acella Sinus Balloon Catheter met all performance criteria." However, it does not elaborate on what those specific criteria were. This is typical for a 510(k) summary for a physical medical device. The criteria would likely involve physical performance metrics like burst pressure, inflation/deflation times, material biocompatibility, and sterilization effectiveness, rather than diagnostic accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document focuses on the physical device and its equivalence to predicates, not on clinical data in the way an AI diagnostic device would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts: Not applicable/Not specified. This device is a physical surgical instrument for dilation, not an AI device that requires expert ground truth for interpretation of medical images or data. Performance testing would likely involve engineering and clinical performance in a procedural context, not expert interpretation of outputs.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/Not specified. This concept is relevant for AI image analysis where disagreements between readers need to be resolved to establish ground truth. For a physical device, performance is evaluated against engineering specifications and clinical outcomes in usability/safety studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical balloon catheter device.
• Effect Size: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For a physical medical device like this, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes (e.g., successful dilation, lack of tissue trauma, safety data) from usability/performance studies. The document does not specify the exact nature of the performance data (e.g., in-vitro bench testing, animal studies, or specific human clinical data beyond general statements of equivalence) or how "ground truth" for those outcomes was established, although it would inherently be based on direct measurement and observation rather than expert interpretation of a model's output.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (balloon catheter) under Class I (Low Risk). It confirms that the device met all specified performance criteria, but the detail expected for an AI performance study (e.g., sample sizes for test/training, expert qualifications, adjudication, MRMC studies) is not present because those concepts are not relevant to this type of device submission. The submission is focused on demonstrating substantial equivalence to predicate physical devices.

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To provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

The Sinus Balloon Catheter—Integrated Wire is a sinus balloon catheter that has an integrated guidewire. The Sinus Balloon Catheter—Integrated Wire allows access to and dilation of the sinus ostia and paranasal spaces with a single device.

The provided text describes a medical device, the "Sinus Balloon Catheter—Integrated Wire," and its 510(k) submission to the FDA. However, the document does not contain the specific details required to complete your request regarding acceptance criteria and the study that proves the device meets them.

The relevant section only states:

"The Sinus Balloon Catheter—Integrated Wire met all performance testing acceptance criteria."

And:

"The Sinus Balloon Catheter—Integrated Wire is substantially equivalent to the predicate devices as confirmed through relevant performance tests."

This indicates that performance testing was conducted and acceptance criteria were met, but the document does not elaborate on:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the given text. This document is a summary of the 510(k) process and regulatory filing, not likely to contain detailed performance study protocols and results. Such details would typically be in an accompanying technical report or design validation documentation, which is not included here.

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The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.

The Relieva Sinus Balloon Inflation Device is a Class I manual surgical instrument for ear, nose, and throat procedures. Its intended use is to inflate, monitor pressure, and deflate balloons during dilation of sinus ostia and paranasal sinus cavities.

Here is a summary of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing focuses on conformance to product specifications for the device itself rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for the device's technical specifications (pressure accuracy, decay, integrity) would be established through engineering and quality control standards, not by medical experts. The "predicate comparison" refers to regulatory comparison, not clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This type of device testing does not involve adjudication by experts as it is focused on technical specifications and substantial equivalence to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This device is a manual surgical instrument, not an AI or imaging diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a manual medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth used for this device's testing would be:

• Engineering Specifications: For Pressure Accuracy, Pressure Decay, and Pressure Integrity, the ground truth would be defined by the device's design specifications and industry standards for pressure measurement and containment in medical devices.
• Regulatory Substantial Equivalence: For the Predicate Comparison, the ground truth is established by the U.S. FDA's criteria for substantial equivalence to legally marketed predicate devices, which involves comparing intended use, technological characteristics, and safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "testing" described refers to quality control and design verification.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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